Like all medicines, this medicine can cause side effects, although not everybody gets them. Zuvixa can be given for three different medical conditions. The known side effects and how frequently they occur for each of these medical conditions may differ and are listed separately below. For these conditions, the most common general side effect of this medicine is bleeding which may be potentially life threatening and require immediate medical attention. The following side effects are known if you take Zuvixa to prevent blood clots from forming after hip or knee replacement operations.
Common side effects (may affect up to 1 in 10 people)
- Anaemia which may cause tiredness or paleness;
- Bleeding including:
- bruising and swelling;
- Nausea (feeling sick).
Uncommon side effects (may affect up to 1 in 100 people)
- Reduced number of platelets in your blood (which can affect clotting);
- Bleeding:
- occurring after your operation including bruising and swelling, blood or liquid leaking from the surgical wound/incision (wound secretion) or injection site;
- in your stomach, bowel or bright/red blood in the stools;
- blood in the urine;
- from your nose;
- from the vagina;
- Low blood pressure which may make you feel faint or have a quickened heartbeat;
- Blood tests may show:
- abnormal liver function;
- an increase in some liver enzymes;
- an increase in bilirubin, a breakdown product of red blood cells, which can cause yellowing of the skin and eyes; - Itching.
Rare side effects (may affect up to 1 in 1,000 people)
- Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact your doctor immediately if you experience any of these symptoms.
- Bleeding:
- into a muscle;
- in your eyes;
- from your gums and blood in your spit when coughing;
- from your rectum; - Hair loss.
Not known (frequency cannot be estimated from the available data)
- Bleeding:
- in your brain or in your spinal column;
- in your lungs or your throat;
- in your mouth;
- into your abdomen or space behind your abdominal cavity;
- from a haemorrhoid;
- tests showing blood in the stools or in the urine;
- Skin rash which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme);
- Blood vessel inflammation (vasculitis) which may result in skin rash or pointed, flat, red, round spots under the skin's surface or bruising.
The following side effects are known if you take Zuvixa to prevent a blood clot from forming in the heart in patients with an irregular heart beat and at least one additional risk factor.
Common side effects (may affect up to 1 in 10 people)
- Bleeding including:
- in your eyes;
- in your stomach or bowel;
- from your rectum;
- blood in the urine;
- from your nose;
- from your gums;
- bruising and swelling;
- Anaemia which may cause tiredness or paleness;
- Low blood pressure which may make you feel faint or have a quickened heartbeat;
- Nausea (feeling sick);
- Blood tests may show:
- an increase in gamma-glutamyltransferase (GGT).
Uncommon side effects (may affect up to 1 in 100 people)
- Bleeding:
- in your brain or in your spinal column;
- in your mouth or blood in your spit when coughing;
- into your abdomen, or from the vagina;
- bright/red blood in the stools;
- bleeding occurring after your operation including bruising and swelling, blood or liquid leaking from the surgical wound/incision (wound secretion) or injection site;
- from a haemorrhoid;
- tests showing blood in the stools or in the urine;
- Reduced number of platelets in your blood (which can affect clotting);
- Blood tests may show:
- abnormal liver function;
- an increase in some liver enzymes;
- an increase in bilirubin, a breakdown product of red blood cells, which can cause yellowing of the skin and eyes;
- Skin rash;
- Itching;
- Hair loss;
- Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact your doctor immediately if you experience any of these symptoms.
Rare side effects (may affect up to 1 in 1,000 people)
- Bleeding:
- in your lungs or your throat;
- into the space behind your abdominal cavity;
- into a muscle.
Very rare side effects (may affect up to 1 in 10,000 people)
- Skin rash which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme).
Not known (frequency cannot be estimated from the available data)
- Blood vessel inflammation (vasculitis) which may result in skin rash or pointed, flat, red, round spots under the skin's surface or bruising. The following side effects are known if you take Zuvixa to treat or prevent re-occurrence of blood clots in the veins of your legs and blood clots in the blood vessels of your lungs.
Common side effects (may affect up to 1 in 10 people)
- Bleeding including:
- from your nose;
- from your gums;
- blood in the urine;
- bruising and swelling;
- in your stomach, your bowel, from your rectum;
- in your mouth;
- from the vagina;
- Anaemia which may cause tiredness or paleness;
- Reduced number of platelets in your blood (which can affect clotting);
- Nausea (feeling sick);
- Skin rash;
- Blood tests may show:
- an increase in gamma-glutamyltransferase (GGT) or alanine aminotransferase (ALT).
Uncommon side effects (may affect up to 1 in 100 people)
- Low blood pressure which may make you feel faint or have a quickened heartbeat
- Bleeding:
- in your eyes;
- in your mouth or blood in your spit when coughing;
- bright/red blood in the stools;
- tests showing blood in the stools or in the urine;
- bleeding occurring after your operation including bruising and swelling, blood or liquid leaking from the surgical wound/incision (wound secretion) or injection site;
- from a haemorrhoid;
- into a muscle;
- Itching;
- Hair loss;
- Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact your doctor immediately if you experience any of these symptoms.
- Blood tests may show:
- abnormal liver function;
- an increase in some liver enzymes;
- an increase in bilirubin, a breakdown product of red blood cells, which can cause yellowing of the skin and eyes.
Rare side effects (may affect up to 1 in 1,000 people)
Bleeding:
- in your brain or in your spinal column;
- in your lungs.
Not known (frequency cannot be estimated from the available data)
- Bleeding:
- into your abdomen or the space behind your abdominal cavity.
- Skin rash which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme);
- Blood vessel inflammation (vasculitis) which may result in skin rash or pointed, flat, red, round spots under the skin's surface or bruising.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly: Website: www.zuventus.co.in and click the tab “Safety Reporting” located on the top right end of the home page. By reporting side effects, you can help provide more information on the safety of this medicine.
